SHEFFIELD, England--()--Simcyp, now part of Certara, the pharmaceutical industry’s leader in providing the most sophisticated platform for the quantitative prediction of drug-drug interactions and pharmacokinetic-pharmacodynamic outcomes in virtual populations, today announces it has extended its repertoire to include a pregnancy model. The additional inclusion of a unique scripting facility, for customising pharmacodynamic response models, allows users more flexibility to code their own models or to use models scripted by others.
“Once again Simcyp has added capability that enables a drug development scientist to explore a clinical scenario that would be very difficult to address, due to ethics and practicality, by clinical investigation in real patients.”
The new pregnancy model enables the full-PBPK modelling of concentration-time profiles of drugs in pregnant women accounting for the physiological and anatomical changes encountered through the gestational period. A ‘Pregnancy Population Library’ is provided with the model which contains all the known changes influencing the handling of drugs throughout the different stages of pregnancy as described in a recent publication by the Simcyp R&D group.
The new custom PD scripting functionality incorporated into Simcyp allows users to introduce their own pharmacodynamic models on top of hundreds of built-in PBPK models. PD model scripts can be written using the Lua scripting language (www.lua.org), a lightweight, powerful, easy to learn language that can be simply embedded in other programs.
Commenting on the new release, Professor Amin Rostami, Vice-President of Research and Development at Simcyp, said: “Several of our collaborators have played a significant role in developing and validating the pregnancy model as manifested by several high impact recent publications in top scientific journals. We are delighted to provide these added benefits to our Simcyp Consortium members through externally funded activities. The user scripting facility expands the horizon for PD capabilities and will encourage the pharmacometrics community to embrace the Simulator and use it for their own complex PD models.”
Reflecting on the expansion of the Simcyp platform, Dr Steve Toon, Vice-President of Consulting Services and Technical Sales Support at Simcyp, commented: “Once again Simcyp has added capability that enables a drug development scientist to explore a clinical scenario that would be very difficult to address, due to ethics and practicality, by clinical investigation in real patients.”
Version 12 Release 2 of the Simcyp Simulator is now available to all Consortium members and academic associates with current not-for-profit license agreements.
Simcyp provides platforms for the modelling and simulation of pharmacokinetics and pharmacodynamics in virtual human populations and virtual laboratory animals (rat, dog & mouse). The technology allows pharmaceutical researchers to predict in vivo outcomes from routinely generated in vitro data, to fit Simcyp models to observed clinical data and to assess inter-individual variability through ‘real-life’ simulations. Simcyp also runs educational workshops, on-site education and provides strategic consultancy in drug development. For more information, visit www.simcyp.com.
Certara is dedicated to improving human health through a broad spectrum of software products and consulting services that enable model-based drug development. Certara was formed by uniting industry leaders Tripos®, provider of innovative scientific software solutions and services enabling life science researchers to improve the efficiency of molecular discovery; Simcyp®, a research-based company providing predictive pharmacokinetic and pharmacodynamics tools, workshops, and consultancy services; and Pharsight® Corporation, provider of software and scientific consulting services to improve productivity and decision-making in preclinical and clinical drug development.
Each Certara family brand has a primary focus and expertise in enabling model-based drug development in a key phase within the drug discovery and development process; combined, they offer a unique set of capabilities for modelling, analysis, and simulation with scientific informatics that can enable the cross-disciplinary approaches necessary for translational science initiatives. For more information, visit www.certara.com.
Representatives from Simcyp are available on request.